Non clinical Study monitor

The work of the Toxicology, Trauma and Medicine Group within the Chemical, Biological and Radiological (CBR) Division aims to prevent or mitigate the lethal and incapacitating effects of chemicals and physical (traumatic) injury. This is achieved by exploring pre- and/or post-exposure pharmaceutical therapies as well as novel concepts for passive protective measures. The work covers early stage innovative research through to clinical development and drug licensure. The research and development outcomes inform a range of strategic and policy decisions across MOD and wider government.

We are seeking a non-clinical study monitor to join the Advanced Development Programme (ADP) team. The successful candidate will join a small and highly skilled, multi-disciplinary team working closely with medical and scientific research colleagues. The primary focus for the successful candidate will be non-clinical scientific co-ordination of product safety studies to support novel pharmaceutical regulatory submission. This will include desk-based research of existing literature and data from innovative efficacy studies, as well as overseeing packages of non-clinical safety studies that are placed at external Contract Research Organisations (CROs).

Dstl recognises the importance of diversity and inclusion as people from diverse backgrounds bring fresh ideas. We are committed to building an inclusive working environment in which each employee fulfils their potential and maximises their contribution.

In this role you will:

• Work collaboratively across inter-disciplinary teams across the non-clinical/clinical interface to ensure robust studies are planned, carried out to the required non-clinical and regulatory standards and reported appropriately.
• Have responsibility for coordinating the activities for non-clinical toxicology studies for regulatory submission, in compliance with the appropriate standards.
• Provide scientific and administrative support to the project team for assigned studies from award, through the in-life phase and reporting.
• Proactively liaise with external contractors and internal project teams to ensure accurate and timely conduct of the agreed studies.
• Manage and conduct interactions with external partners to ensure positive and trusted relationships are developed.
• Provide proactive support to suggest and implement action plans for solving study problems should they occur
• Apply regulatory requirements and guidance effectively to define non-clinical project strategies.
• Contribute to regulatory documentation and submissions to MHRA.
• Provide robust and reliable toxicology advice to MOD stakeholders to enable informed decision making.
• Write literature reviews pulling together data from a variety of studies to inform project outcomes.

We are looking for someone with the following;

Essential Qualifications
•    Degree in Biomedical, Biochemical, Biological or Pharmaceutical Sciences (or equivalent)

Desirable Qualifications
•    Post-graduate certifications in toxicology, regulatory affairs or product safety

Essential Experience
•    Previous or current experience as a GLP Study monitor/Study director
•    Non-clinical study experience in pharmaceutical development.
•    Demonstrable experience of writing and reviewing study protocols and reports
•    An effective team player
•    Good IT Skills – proficient in MS Office Word, Excel, PowerPoint and Outlook.

Desirable Experience
•    Experience of toxicology and/or pharmacology in pharmaceutical development
•    Experience of managing internal and subcontracted non-clinical studies.
•    Experience in a client facing role
•    Excellent communication and time management skills
•    Excellent attention to detail and consistent accuracy whilst managing multiple changing priorities
•    Knowledge of regulatory agency guidelines and Home Office requirements
•    Experience of ADME/DMPK principles

Important Information

Our work in defence, security and intelligence requires our employees to be UK Nationals who are able to gain a high level of security clearance to undertake the projects we are involved in to protect us from security threats. For this reason, only UK Nationals will be able to apply for this role. If you are an international or dual-national candidate, and you think you have the skills we need, please consider applying to any of our government, security or defence partners.

 This role will require full UK security clearance and you should have resided in the UK for the past 5 years. For some roles Developed Vetting will also be required, in this case you should have resided in the UK for the past 10 years.

We’ll assess you against these behaviours during the selection process:

• Communicating and Influencing
• Delivering at Pace
• Working Together
• Developing Self and Others

We’ll assess you against these technical skills during the selection process:

• Please tell us how you would approach study design

Benefits 

Dstl’s full range of great benefits can be found in the information pack which includes:

• Financial: An excellent pension scheme starting from 26% employer contribution (find out more here). In Year Rewarding Achievement bonuses and thank you vouchers. Rental deposit scheme and cycle to work scheme.

• Flexible working: Options include alternative working patterns such as; compressed hours (e.g. working a 4 day week/ 9 day fortnight), job shares and annualised hours (agreed number of hours per annum paid monthly i.e. working term-time only).

• Working hours: Flexibility around your working day (e.g. start time, finish time). Ability to bank hours in a 12 month reference period including the ability to accrue and use 3 days per calendar month.

• Where you work: Depending on your role, blended working may be available including remote working to suit you and your team. This can be discussed at interview.

• Annual leave: 25 days pro rata (rising to 30 after 5 years) plus 8 public holidays with the ability to buy/sell 5 additional days per annum.

• Family: Maternity, adoption or shared parental leave of up to 26 weeks with full pay, an additional 13 weeks statutory pay and a further 13 weeks unpaid

• Learning and Development: Dstl encourages and supports charterships, accreditations and provides employees access to fully funded apprenticeships up to level 7 (Masters Degree). Dstl will pay for 2 memberships with relevant bodies/institutions. Employees also have access to Civil Service Learning.

• Facilities: Onsite parking, EV Charging points, restaurants, cafés and gyms.

This job is not open to candidates who hold a dual nationality.

Job contact :

• Name : dstl recruitment
• Email : dstlrecruitment@dstl.gov.uk

Recruitment team

• Email : dstlrecruitment@dstl.gov.uk